Work Schedule
Other

Environmental Conditions
Office

Job Description

Join us as a Scientist!

Essential Qualifications:
• Bachelor's degree in Packaging Engineering, Packaging Science, Chemistry, Life Science, with 2-4 years' experience in parenteral package development, primarily in pharmaceutical industry
• Analytical and/or lab based experience in the pharmaceutical industry

Preferred Qualifications:
• Knowledge of parenteral packaging materials, components, vendors, analytical equipment, and technologies.
• Experience in sterile drug primary packaging development for large and small molecules including vial/stopper, pre-filled syringes, and cartridges presentations.
• Knowledge of domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).
• Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.
• Ability to quickly establish relationships with internal and external stakeholders.
• Strong time management / organizational skills.
• Evidence of team working skills and flexibility.

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Work Summary:

To provide packaging development analytical support in the UP, PA site.
The task list outlined below provides a comprehensive summary of the crucial work that needs to be carried out in the Steriles Packaging Development lab/team. This work is primarily aimed at offering support for a multitude of projects related to Steriles ViiV projects in development at GSK.

Tasks:
• Perform timely execution of lab based analysis, including experiment write up to support sterile primary package selection, integrity, stability, and lifecycle for the coordination and testing of samples
o Examples of analytical technique include extrusion force testing, stopper movement assessment, CCI capabilities including HeLD, Vacuum Decay, and headspace analysis
• Be a practical expert in a packaging/analytical technique relevant to a primary pack presentation, capable of training others in the technique and application
• Collaborate with the Lab Manager to maintain the License To Operate (LTO) status in the Lab - including equipment maintenance, documentation and coordination with vendors, management monitoring, and safety requirements
• Maintain packaging lab component and lab inventory, including ordering, receiving, and organization of lab space to enable dynamic, flexible laboratory workspace
• Prepare and communicate data summaries to relevant project team members

Stretch Tasks:
• Writing work instructions, study protocol contribution
• Authoring/revising component specifications
• Supporting document and knowledge management

Working Conditions and Environment:
• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
• Occasional mobility needed.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.